Estimating rates of multiple gestation pregnancies: Sample size calculation from the assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial

Michael P. Diamond, Mohamed Mitwally, Robert Casper, Joel Ager, Richard S. Legro, Robert Brzyski, Peter Casson, Esther Eisenberg, Heping Zhang

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

Infertility afflicts 15% of couples who wish to conceive. Despite intensive evaluation of both male and female partners, the etiology may remain unknown leading to a diagnosis of unexplained infertility. For such couples, treatment often entails ovulation induction (OI) with fertility medications coupled with intrauterine insemination. Complications of this therapy include ovarian hyperstimulation syndrome and creation of multiple gestation pregnancies, which can be complicated by preterm labor and delivery, and the associated neonatal morbidity and expense of care for preterm infants. The Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) study is designed to assess whether OI in couples with unexplained infertility with an aromatase inhibitor produces mono-follicular development in most cycles, thereby reducing multiple gestations while maintaining a comparable pregnancy success rate to that achieved by OI with either gonadotropins or clomiphene citrate. These results will provide future guidance of therapy for couples with unexplained infertility, and if comparable pregnancy rates are achieved with a substantial reduction in multiple gestations, the public health benefit will be considerable.

Original languageEnglish (US)
Pages (from-to)902-908
Number of pages7
JournalContemporary Clinical Trials
Volume32
Issue number6
DOIs
StatePublished - Nov 2011

All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)

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